The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
The duration of treatment is 104 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,172
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Change From Baseline in HbA1c at Week 52
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.
Time frame: Baseline and Week 52
Change From Baseline in HbA1c at Week 104
HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
Time frame: Baseline and Week 104
Change From Baseline in Body Weight at Week 52
Change from baseline at Week 52 is defined as Week 52 minus Week 0.
Time frame: Baseline and Week 52
Change From Baseline in Body Weight at Week 104
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Time frame: Baseline and Week 104
Hypoglycemic Events at Week 52
Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.
Time frame: Baseline to Week 52
Hypoglycemic Events at Week 104
Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.
Time frame: Baseline to Week 104
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
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Time frame: Baseline to Week 104
Number of Participants With Serious CAEs at Week 104
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
Time frame: Baseline to Week 104
Number of Participants With Drug-related CAEs at Week 104
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
Time frame: Baseline to Week 104
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Time frame: Baseline to Week 104
Number of Participants With Serious LAEs at Week 104
Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Time frame: Baseline to Week 104
Number of Participants With Drug-related LAEs at Week 104
Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.
Time frame: Baseline to Week 104